Cannula, manipulator/injector, uterine: medical device reports filed with FDA

1,788 reports carry this product code, 1992–2026; 6 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,788
reports with this product code: 0% of all MAUDE reports; 98
reports, 12 months to August 2026: 109 in the 12 months before; 82.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code LKF is FDA's classification for "Cannula, manipulator/injector, uterine" (obstetrics/Gynecology panel), a class 2 device. 1,788 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

98 reports arrived in the 12 months to August 2026, down 10% from 109 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (82.2%), injury (13.9%) and other (1.8%). 6 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Vcare	324	71	0%	91.7%
Uterine Manipulator - 7cm	192	0	0%	94.8%
Vcare 200a - Medium	163	0	0%	92.6%
Cook Silicone Balloon Hysterosalpingography Injection Catheter	29	0	0%	97.6%
Conmed	3	89	0.2%	65.6%
Endopath	1	74	1.4%	83.7%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Conmed	709	39.7%
Coopersurgical	195	10.9%
Ethicon Endo-Surgery	151	8.4%
Ethicon Endo Surgery Cincinnati	31	1.7%
Ethicon Endo-Surgery Cincinnati	26	1.5%
Ethicon Endo Surgery	8	0.4%
Aesculap	1	0.1%
Richard Wolf	1	0.1%
Stryker Endoscopy	1	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%2

Injury13.9%249

Malfunction82.2%1,470

Other1.8%32

Not given2%35

Who filed

Manufacturer report68.1%1,217

Voluntary report14.8%264

User facility report0%0

Distributor report0.3%6

Not given16.8%301

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	281	15.7%
Detachment of device or device componentpart of the device came off	220	12.3%
Detachment of device component	168	9.4%
Inflation problem	118	6.6%
Material separation	116	6.5%
Replace	110	6.2%
Material fragmentation	106	5.9%
Unintended movement	91	5.1%
Burst container or vessel	88	4.9%
Balloon rupture	45	2.5%
Tip breakage	44	2.5%
Material rupture	37	2.1%
Balloon burst	35	2%
Deflation problem	31	1.7%
Component falling	30	1.7%
Failure to deflate	29	1.6%
Improper or incorrect procedure or method	27	1.5%
Component(s), broken	26	1.5%
Difficult to removethe device was hard to remove	24	1.3%
Device operates differently than expectedthe device behaved unexpectedly	22	1.2%

Questions about cannula, manipulator/injector, uterine reports

What is product code LKF?

FDA's classification code for "Cannula, manipulator/injector, uterine", class 2, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,788 reports through August 2026, 98 of them in the latest 12 months.

Which brands appear most often?

Vcare (324), Uterine Manipulator - 7cm (192), Vcare 200a - Medium (163), Cook Silicone Balloon Hysterosalpingography Injection Catheter (29) and Conmed (3). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.